The 'stepped approach' used recommends that doctors start with low doses or weaker medications and progress to higher doses or stronger medication over time until the discomfort is eased.

While the first things here are not medications, these are the steps that are recommended in the guidelines:

1. Feed thickeners or thickened formula milks
2. Alginate therapy (e.g. Gaviscon)
3. Gastric Acid Suppression medications

Under the guidelines, the prescribing doctor has discretion about which GAS medication they prescribe:

• Histamine-2 Receptor Antagonists (H2RA) such as ranitidine*, cemetidine, (Zantac)
• Proton Pump Inhibitors (PPI) such as omeprazole, esomeprazole, pantoprazole, lanoprazole (Nexium, Prevacid)
• Domperidone, a motility drug
• Ketotifen, Ceteridine, Piraton (anti-histamines)

There are other classes of medications also used for babies with reflux for various reasons:

• Antibiotics (specifically Erythromycin)
• Laxatives such as Movicol and Lactulose

This is a quick overview of what the medications do and how they can help, this is only the start of the conversation:

1. Feed thickeners or thickened milks
These simply make the milk in baby's tummy thicker so that it cannot be regurgitated quite so easily. This changes the milk, not the cause of the reflux or vomit that they are trying to address. They make vomiting of the milk more difficult for the body.
 

2. Alginate therapy (e.g. Gaviscon)
These form a raft on top of the stomach contents, with the aim of keeping food in the stomach and stopping the vomiting. They do not address the cause of the vomiting. 

3. Histamine-2 Receptor Antagonists. (H2RA) e.g. ranitidine / Zantac
These inhibit the attachment of Histamine-2 to its receptor cells in the stomach which alters the composition of stomach acid. 

This reduces the acidity of your baby stomach acid and therefore reduces the "burning" sensation they get from regurgitated acid in their oesophagus.

They also delay gastric emptying - keeping food in the stomach longer, and increase the contractions of the stomach (which have the potential to make things worse). [Reference]

These medications don't work immediately, they must pass into the bloodstream first to get to the H2 receptors to block them. The other organ in the body that uses H2 is the heart, and some studies in older patients has shown changes to heart rate pressure (very little research has been carried out for infants and these medications). [Reference]
 

4. Proton Pump Inhibitors (PPI) e.g. omeprazole, lansoprazole, Nexium
These medications work by blocking the proton pumps in the stomach, the cells that release stomach acid.

This is a more aggressive form of gastric acid suppression therapy than H2RA's. They were designed to combat "over production of stomach acid"... The desired outcome is the same, to stop the regurgitated food from burning the oesophagus.

As with the H2RA's, they do not stop the regurgitation. They also delay gastric emptying - keeping food in the stomach longer, and increase the contractions of the stomach (which have the potential to make things worse). [Reference]
 

5. Ketotifen, (Zatiden), Ceterizine, Piraton
These are anti-histamines. They are usually prescribed for asthma sufferers or for hay-fever,

However, they are being prescribed more and more to infants with reflux who present as having developed allergies as a way to try and manage the body's allergy response. 

Frequently, the effects and changes are not long-lasting.

6. Domperidone - Scroll down to watch the video on this medication.

No medications are completely free from side effects. And we tend to ignore the patient leaflets that come with our medications... However, it is important to understand these because in some instances, the medications can also contribute to what we are trying to stop!

Firstly - a quick summary of what side effect ratings mean. These are standard definitions used for medications.

• Very Common - Between 10% and 100% of people taking the medication will experience this.
• Common - Between 1% and 10% will experience these
• Rare - Between 0.1% and 1% will experience these
• Very Rare - Less than 0.1% (1 in 1,000) will experience these

Now... what are the side effects that can be experienced with the medications that are used to manage infant reflux? 

1. Feed thickeners or thickened milks
   Feed thickeners are not issued with any advice on potential side effect.
   
   However.... the thickening agent in them (maltodextrin, rice starch, corn, tapioca, potato etc) all have the propensity to cause flatulence, bloating and trapped wind as well as some of them being allergens in their own right (e.g. maltodextrin which is sometimes used in the "allergy free" amino acid milks). Have a watch for more info:
   
   
    
2. Alginate therapy (e.g. Gaviscon)
   There are no listed side effects of alginates. However, they do contribute to constipation which some parents find is worse than the reflux. This is very individual by each baby and so you will not know if you do not try.
   
   Be sure that you baby is on the infant version of these medications and not the adult version. The adult versions contain aluminium which is associated with bone disease later in life because it impairs the absorption of phosphate in the stomach (vital for bone growth) [Reference]
   
   In a recent Instagram poll, where over 100 parents answered, 72% of parents said that their baby had constipation when on the Gaviscon. Yet this is not listed as a side effect... 
   
   
3. Histamine-2 Receptor Antagonists. (H2RA) e.g. ranitidine / Zantac
   Uncommon side effects are listed as "some abdominal discomfort/pain, constipation, nausea, vomiting". Even though some of these are what we are trying to resolve? [Reference]
   
   Additionally, H2RA's stop the uptake of histamine by the body, which causes the body to produce more histamine to try and get the stomach acid produced.
   
   As a result, histamine blood levels increase which can build over time and cause a histamine sensitivity issue. This is a major issue if it arises because baby will literally react to every food they eat. This is not researched, this is my observations fo what is happening with many of my clients babies. Once we get histamine levels under control again, baby can enjoy most foods.
    
4. Proton Pump Inhibitors (PPI) e.g. omeprazole, lansoprazole, Nexium
   Side effects listed as Common or Very Common are abdominal pain; constipation; diarrhoea; dizziness; dry mouth; gastrointestinal disorders; headache; insomnia; nausea; skin reactions; vomiting [Reference]
   
   The following side effects have been proven to show in infants 
• Increases risk of acute gastroenteritis [Reference]
• Increases risk of community-acquired pneumonia [Reference]
• Increases incidence of intestinal and respiratory infections in otherwise healthy children, and this risk remains after the drug therapy stops [Reference]
• Increases incidence of necrotising enterocolitis in pre-term infants  [Reference]
• Shows higher frequency of small intestine bacteria overgrowth (SIBO) causing abdominal pain, bloating, eructation (burping), and flatulence [Reference]
• Increases risk of candidemia (candida fungal infection that can be fatal if not appropriately diagnosed and treated) in neonatal intensive care units [Reference]
• Increases occurrence of lower respiratory tract infections considered to be serious adverse events (infants, PPI)  [Reference]
• Shows higher incidence of bone fracture in childhood after PPI use [Reference]
  
  And the list doesn't stop there... there are more side effects for PPI medications that have only been proven in adults - which doesn't make them less applicable to babies. More details on these are in my book.
  
  
5. Ketotifen, (Zatiden)
   The side effects listed as common or very common are anxiety; insomnia; irritability. There are of course more side effects, but if your baby is prescribed Ketotifen then usually nothing else has worked so far and I would argue that the cause has not been addressed. [Reference]

We assume that any medications that would be prescribed for our babies would be approved and be safe for use with them... wouldn't we? Is this not a reasonable assumption to make?

You must also determine what you understand and accept as "safe". What does safe mean to you?

Does it mean

• "will it cause death?" or
• "will it cause any harm?" or
• "is it completely free of any side effects?" or
• "will it cause long-term side effects?" or
• "will it increase my baby's risk of other illnesses later in life?"

Your personal interpretation of safe is really important, and it's okay to have a different interpretation to me or to anyone else. This is your responsibility. What I consider safe is not necessarily what a doctor would consider safe. So you must find your own interpretation of that.

 Of the medications I spoke about in the previous questions (1-3), these are what we have to be aware of 

1. Alginate therapy
   Ensure that you are prescribed the infant version. I know babies who have been given the adult version. This is not safe for infants as it contains aluminium which could cause long term issues given its strength versus their weight.
    
2. H2RA's (e.g. ranitidine, famotidine, Zantac)
   See the information on ranitidine which was recalled from most of the world between November 2019 and April 2020 for a carcinogenic contamination problem. As of May 2023, the medication is still not available in most of the western world.
   
   Famotidine is being prescribed more frequently in the USA while "The safety and efficacy for the use of Famotidine in children has not been established." [children being people under the age of 12 years] [Reference]
   
   From most reading, it appears that H2RA's are not considered safe under 12 months, o 12 years depending on the specific medication 
    
3. Proton Pump Inhibitors (PPI's, -prazole)
   I must be clear here - there is only one variant of these medications that is currently approved for use in infants. That is an oral suspension of omeprazole. However, that is not the only PPI drug prescribed by our doctors. 
   
   What does this mean? This means that the manufacturers themselves are stating that these drugs should not be used in children under 12 months of age. By prescribing these drugs, our doctors are taking on this liability and ignoring advice by the manufacturers.

In short, the more common medications are not proven for use and so we need to take this into account when we make our decisions. 

If you decide you give your baby medication for their reflux, how long should you wait to see positive results from it? This is a critical question because I'm seeing a lot of babies react badly to the medications very quickly and the response of the doctor is to increase the medication dosage rather than say "it's not working".

In these cases, it very often tends to be the parents deciding that the medication isn't working for their baby and not their doctor.

So working through the process of what gets prescribed. How quickly should it work and why. What has your doctor told you?

1. Smaller more frequent feeds
   This should work immediately if your baby's only issue is too much in their stomach. Typically this doesn't work for anyone except tiny babies who don't yet have elasticity in their stomach.
   
   The reason is that reflux isn't caused by the amount of milk in their tummy, it is usually from the amount of air in their tummy with the milk.
   
   
2. Feed thickeners or thickened milks
   Again, this should be an instant improvement if all that is wrong is baby's lower oesophageal valve strength not being strong enough to keep contents.
   
   What might develop over the following week or so is constipation, wind and other gastro intestinal disturbances if the milk is fermenting because the thickeners are not digestible, or constipation as the thickeners start to absorb more fluid from baby's body.
   
   Other negative side effects, like allergy reactions to ingredients in them (e.g. maltodextrin) can be rather quick, from hours to days as well.
   
   
3. Alginates
   Improvements - or reduced vomiting / possessing / reflux should be immediate. These form a raft on the top of the stomach contents and so should start to work immediately (as in after the meal/feed with which the medication is given).
   
   Constipation can set in rather quickly as well as these medications absorb fluid from the entire digestive tract.
   
   
4. H2RA's
   The improvement from these won't be seen immediately because these need to get through the stomach and into the small intestine before the medication is absorbed, and then circulated in the blood to get to the Histamine-2 receptor sites (stomach and heart). Only when they have attached to these sites can they start to reduce the amount of histamine "received" by the receptor sites and alter the state of stomach acid.
   
   Because we usually start with lower levels of medication, you may find that these take up to 2 weeks to work.
   
   Negative and allergy reactions can happen immediately.
   
   
5. PPI's
   These work faster than H2RA medications because they block the proton pumps on the lining of the stomach itself. However, there is a ramp-up needed for these medications to start working effectively.
   
   During this "ramp-up" period, reflux can get worse, much worse.
   
   This also triggers an immediate increase in histamine production in the stomach. However, with the pumps blocked, the higher histamine levels means the brain will continue telling the stomach to produce more and more acid. 
   
   This is sort of a cat and mouse game to force baby's body to its threshold for acid production until the PPI works. 
   
   It's known as the "Acid Battle". The acid battle also happens when weaning off the medications. 
   
   It's based on the the belief that it's okay and normal to make things worse before they are made right. 

This is an important question, and I think it's one we tend to not ask. I think this is for one of two reasons, either  

1. We are either afraid that the answer is going to be rather ambiguous
2. We assume that the medication will work, why else would our doctors prescribe it?

I'm going to share with you some statistics coming out of the survey I've been running since May 2017 [click here if you would like to add your voice].

90% of babies diagnosed with reflux or CMPA are on prescription medications

76% of these babies continue to suffer with reflux problems?

This demonstrates that the medications are not exactly the be-all and end-all for treating reflux.

And the number of babies on medications who are over 12 months who haven't "grown out of it" by that magic 12-month mark is surprisingly high.

If your GP tells you that the medication is guaranteed to resolve your baby's issues and troubles, then you know that this is not the case.

They cannot possibly know this.

And if the medications worked for every baby, then why do you need to battle so long to see them working and why do they get worse, uncontrollable even when food is introduced into the equation?

There isn't a full answer to this question. And there are a lot of studies out there that show that there is little to no difference between using gastric acid suppressing medications (i.e. omeprazole, ranitidine and other PPI's and H2RAs) for managing reflux. Here's a link to a few if you're interested in having more reading.

• "PPIs are not effective in reducing GERD symptoms in infants. Placebo-controlled trials in older children are lacking. Although PPIs seem to be well tolerated during short-term use, evidence supporting the safety of PPIs is lacking." [Reference]
• "Previously assumed safety of these medications is being challenged with evidence of potential side effects including GI and respiratory infections, bacterial overgrowth, adverse bone health, food allergy and drug interactions" [Reference]
  

If you're in the UK, then the NICE guidelines state that babies should have a trial of gastric acid suppressing medications (either a H2RA or a PPI - the guidelines leave the choice of which up to the individual doctor) for up to four weeks. If after four weeks there is no improvement, then the infant should be referred to a specialist paediatrician. 

And then what? 

You're waiting.

For how long?

A week or two if you're lucky and have private medical cover. Perhaps up to three months in some places. And meanwhile what are you supposed to do to help your baby?

This is quite a bleak outlook in my opinion. 

And the truth of the reality of practice is not much better. 

What generally happens is that baby is given a trial of one of the medications (usually a H2RA - ranitidine). If that does't work then the dose is increased, and then again. Perhaps then the doctor adds a PPI (usually omeprazole but not always), and continues to increase the dose to try and help baby. 

All the time, your baby continues to suffer, perhaps there has been some marked improvement, like the arching with pain from the regurgitated acid isn't there (the regurgitation doesn't necessarily stop with the medications).

Perhaps they will tell you to stop breastfeeding, or change the milk to a specialist milk. 

And still you have no referral, you have no answers, your baby continues to suffer and you do too. The emotional and mental toll that watching your baby suffer without being able to help is horrendous. 

Over 55% of babies are still on medications by12 months of age.

Three months is considered "long term use" of gastric acid suppressing medications in adults. In fact, some of the PPI manufacturers state that people should "take no more than one 14-day course of treatment of therapy every 4 months unless otherwise directed by a physician." [Reference]

My question is that how can our doctors determine be more confident in the long-term use of these medications when the manufacturers are not willing to insure against adverse effects past what they state on their literature? 

Interestingly, we frequently see baby's medication doses maxed out to match their body weight (or even more) to try and numb the symptoms, yet this brings on medication dependency... "Patients requiring higher initial doses to achieve effective symptom relief are more likely to require continued therapy as well....The treatment itself may also predispose patients to a need for ongoing therapy" [Reference]

So how long will your baby be on these medications?

The answer is completely unknown.

A number of my private clients' baby's have been on various forms of medications for over a year, with no signs of being able to wean from them. And in truth, once we understood the cause of their reflux and then weaned appropriately (unique approach for each child), they have been free of reflux, and happier, more contented children overall. The challenge is that they are now children, their baby days are past them and their parents question whether their doctors made the right decision in the first place to ever prescribe medications that never seemed to help.

The review period for these medications in babies should be no more than four weeks, and every four weeks, yet I have known many babies to be left on the medications without formal and regular reviews booked in to see if they need to remain on them and why.

For many of the families I work with, getting off the medications is massively important. They weren't sure about medications in the first place, they aren't sure that they work, and they don't know if they are helping or hindering their baby.

With a client recently, we discovered that her son had developed a histamine sensitivity issue because of the way the medications work, and his reflux was flaring so badly. Her goal of working with me was to get him off the meds as quickly as possibly.

They had tried 3 times over the previous 5 months and each time the reflux flares from weaning were worse than ever before.

The advice she had had about weaning the medications had failed her 3 times.

The prescribing doctor had said reduce it by 5ml (from 20) every few weeks, another person said reduce by 5mg, then increase back to 20mg, and yo-yo like this for a week, another piece of advice was to reduce by 2mg one day a week, then 2 days the following week, 3 days the following week and so forth until baby was on 18ml and settled, and then start all over again.

This last process would have seen baby on the medications for another 70 weeks!!! So needless to say she wasn't happy about these.

Because her little guys histamine sensitivity complicated things a bit more, we used it in our favour. And in 21 days, her boy is medication free, and happy again. Now we can allow his body to re-establish it's natural histamine levels and hopefully he will be eating everything on the Christmas dinner table without issues.

Always ask your doctors this question. The nature of these medications is that the minute you try and remove them, they produce what some people (not me) believe to be a cause of reflux - a true, if artificial excess of stomach acid. Which means that reflux flares are inevitable as part and parcel of coming off the medications.

Sometimes the flares are so bad that babies end up on the medicines much much longer than they should be.

And this artificial flare of reflux is caused by the medications, so please don't mistake it as a "failed" wean, it actually means that your baby's body is trying to normalise itself and working just fine.

If you have tried weaning from medications and it hasn't worked, I do consultations for families to work through this and free your family of reflux completely.